Atropine Sulfate
ATROPINE SULFATE- atropine sulfate injection, solution
Amneal Pharmaceuticals LLC
1 INDICATIONS AND USAGE
Atropine sulfate injection is indicated for temporary blockade of severe or life-threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest.
2 DOSAGE AND ADMINISTRATION
2.1 General Administration
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer unless solution is clear and seal is intact. Each syringe is intended for single-dose only. Discard unused portion.
For intravenous administration.
Titrate based on heart rate, PR interval, blood pressure and symptoms.
2.2 Adult Dosage
Table 1: Recommended Dosage
| Use | Dose (adults) | Repeat |
| Antisialagogue or other antivagal | 0.5 mg to 1 mg | 1 to 2 hours |
| Organophosphorus or muscarinic mushroom poisoning | 2 mg to 3 mg | 20 to 30 minutes |
| Bradyasystolic cardiac arrest | 1 mg | 3 to 5 minutes; 3 mg maximum total dose |
2.3 Pediatric Dosage
Dosing in pediatric populations has not been well studied. Usual initial dose is 0.01 mg/kg to 0.03 mg/kg.
2.4 Dosing in Patients with Coronary Artery Disease
Limit the total dose of atropine sulfate to 0.03 mg/kg to 0.04 mg/kg [see Warnings and Precautions (5.1)].
3 DOSAGE FORMS AND STRENGTHS
Atropine Sulfate Injection USP, 0.5 mg/5 mL (0.1 mg/mL) is available as a sterile, clear, colorless solution supplied in 5 mL single-dose glass syringe for intravenous administration.
4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS
5.1 Tachycardia
When the recurrent use of atropine is essential in patients with coronary artery disease, the total dose should be restricted to 2 mg to 3 mg (maximum 0.03 mg/kg to 0.04 mg/kg) to avoid the detrimental effects of atropine-induced tachycardia on myocardial oxygen demand.
5.2 Acute Glaucoma
Atropine may precipitate acute glaucoma.
5.3 Pyloric Obstruction
Atropine may convert partial organic pyloric stenosis into complete obstruction.
5.4 Complete Urinary Retention
Atropine may lead to complete urinary retention in patients with prostatic hypertrophy.
5.5 Viscid Plugs
Atropine may cause inspissation of bronchial secretions and formation of viscid plugs in patients with chronic lung disease.
6 ADVERSE REACTIONS
The following adverse reactions have been identified during post-approval use of atropine sulfate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Most of the side effects of atropine are directly related to its antimuscarinic action. Dryness of the mouth, blurred vision, photophobia and tachycardia commonly occur. Anhidrosis can produce heat intolerance. Constipation and difficulty in micturition may occur in elderly patients. Occasional hypersensitivity reactions have been observed, especially skin rashes which in some instances progressed to exfoliation.
7 DRUG INTERACTIONS
7.1 Mexiletine
Atropine sulfate injection decreased the rate of mexiletine absorption without altering the relative oral bioavailability; this delay in mexiletine absorption was reversed by the combination of atropine and intravenous metoclopramide during pretreatment for anesthesia.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Animal reproduction studies have not been conducted with atropine. It also is not known whether atropine can cause fetal harm when given to a pregnant woman or can affect reproduction capacity.
8.3 Nursing Mothers
Trace amounts of atropine was found in breast milk. The clinical impact of this is not known.
8.4 Pediatric Use
Recommendations for use in pediatric patients are not based on clinical trials.
8.5 Geriatric Use
An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
10 OVERDOSAGE
Excessive dosing may cause palpitation, dilated pupils, difficulty in swallowing, hot dry skin, thirst, dizziness, restlessness, tremor, fatigue and ataxia. Toxic doses lead to restlessness and excitement, hallucinations, delirium and coma. Depression and circulatory collapse occur only with severe intoxication. In such cases, blood pressure declines and death due to respiratory failure may ensue following paralysis and coma.
The fatal adult dose of atropine is not known. In pediatric populations, 10 mg or less may be fatal.
In the event of toxic overdosage, a short acting barbiturate or diazepam may be given as needed to control marked excitement and convulsions. Large doses for sedation should be avoided because central depressant action may coincide with the depression occurring late in atropine poisoning. Central stimulants are not recommended.
Physostigmine, given as an atropine antidote by slow intravenous injection of 1 mg to 4 mg (0.5 mg to 1 mg in pediatric populations), rapidly abolishes delirium and coma caused by large doses of atropine. Since physostigmine is rapidly destroyed, the patient may again lapse into coma after one to two hours, and repeated doses may be required.
Artificial respiration with oxygen may be necessary. Ice bags and alcohol sponges help to reduce fever, especially in pediatric populations.
Atropine is not removed by dialysis.
11 DESCRIPTION
Atropine sulfate injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfate monohydrate in water for injection with sodium chloride sufficient to render the solution isotonic. It is administered parenterally by intravenous injection.
Each milliliter (mL) contains 0.1 mg (adult strength) of atropine sulfate monohydrate equivalent to 0.083 mg (adult strength) of atropine, and sodium chloride, 9 mg. May contain sodium hydroxide and/or sulfuric acid for pH adjustment.
0.308 mOsmol/mL (calc.).
pH 3.0 to 6.5.
Sodium chloride added to render the solution isotonic for injection of the active ingredient is present in amounts insufficient to affect serum electrolyte balance of sodium (Na+) and chloride (Cl–) ions.
The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended for use only as a single-dose injection. When smaller doses are required the unused portion should be discarded.
Atropine sulfate, USP is chemically designated 1α H, 5α H-tropan-3-α-ol (±)-tropate (ester), sulfate (2:1) (salt) monohydrate, (C17 H23 NO3 )2 H2 SO4 H2 O, colorless, almost white to white solid. It is very soluble in water and glacial acetic acid, freely soluble in ethanol (96%) and practically insoluble in diethyl ether. It has the following structural formula:
Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and 1-hyocyamine, whose activity is due almost entirely to the levo isomer of the drug.
Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.
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